The following data is part of a premarket notification filed by Ni Medical with the FDA for Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim.
| Device ID | K070500 |
| 510k Number | K070500 |
| Device Name: | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM |
| Classification | Plethysmograph, Impedance |
| Applicant | NI MEDICAL 414 MARYJOE WAY Warrington, PA 18976 |
| Contact | James Collie |
| Correspondent | James Collie NI MEDICAL 414 MARYJOE WAY Warrington, PA 18976 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-21 |
| Decision Date | 2007-07-16 |
| Summary: | summary |